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Data, Freedom of Information releases and corporate reports
Background information for MHRA AI Airlock launched in Spring 2024 and is the MHRA’s first regulatory sandbox for AI as a Medical Device (AIaMD) products.
The types of emissions a manufacturer or importer of e-cigarettes should notify us about.
A pathway summarising the processes pharmaceutical companies should follow when preparing to launch new products in the UK.
Advice for manufacturers, members of the public and professional users of software or apps being used during the COVID-19 pandemic.
For manufacturers reporting adverse incidents with intraocular lenses under the vigilance system.
Report on the service providing sterile, controlled environments for the preparation of injectable medicines into ready-to-administer formats for patients.
The MHRA has published advice for patients and healthcare professionals
The VDEC clinical evaluation team works to support vaccine and therapeutic development by providing expertise in immunological and functional assays used to support clinical trials (Phase I to IV)
The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19
Guidance for clinical trials that use Decentralised Manufactured Investigational Medicinal Products (IMPs).
Guidance for manufacturers of artificial heart valves. It outlines specific scenarios that should be considered when determining if an incident is reportable.
These temporary good manufacturing practice (GMP) flexibilities will be allowed to address the current exceptional circumstances
Information for retailers from Great Britain supplying medical devices to Northern Ireland.
How the MHRA assesses marketing authorisation applications (MAA) for medicines referred under Article 29.
Video series explaining the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland.
Information for patients, healthcare professionals and the wider public to help better understand the importance of AAIs as a potential life-saving medicine.
How to test and report levels of nicotine uptake when submitting a notification of intent to market e-cigarette and vape products in Great Britain.
Due diligence for suppliers of e-cigarettes and e-liquids.
Guidance and specifications for the recording and extraction of CTAD data from laboratories in England processing LA and NHS commissioned chlamydia tests.
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